What's new in July 2008

New for July

• 31 Jul 2008| MDA/2008/059 - Blood glucose meters – Ascensia Contour (5-second) manufactured by Bayer Diabetes Care

  This Medical Device Alert has been issued as affected devices may show falsely high readings when testing samples from neonates less than 24 hours old.  This may mask hypoglycaemia.

• 31 Jul 2008| Public consultation ARM 54: Request to reclassify a bottle presentation of Calpol Six Plus Suspension Sugar Free from Pharmacy (P) to General Sales List (GSL)

  Reminder: Closing date for comments is 6 August 2008.
  ARM 54 seeks your views on the reclassification from P to GSL of a bottle presentation of Calpol Six Plus Suspension Sugar Free.

• 30 Jul 2008| MDA/2008/058 - Medi-Tec Classic hoist manufactured by Aidservice Ltd

  This Medical Device Alert has been issued after the MHRA received reports of two incidents where the spreader bar detached from the boom of the hoist while it was in use.

• 29 Jul 2008| Alert: Impersonation of MHRA staff

  We have again been alerted that there have been calls made to companies recently from people purporting to be members of MHRA staff, but who do not work for the Agency.

• 29 Jul 2008| MHRA Annual Report and Accounts 2007/08

  We have today published our Annual Report and Accounts 2007/08.

• 29 Jul 2008| Hot Topics in Advertising Seminar - Half Day

  We will be hosting a half-day seminar on advertising and information about medicines. This will provide insight into current advertising hot topics and an explanation of the regulations and MHRA expectations.
  

• 28 Jul 2008| MDA/2008/057 - Urine collection bottle - 24 hour urine container manufactured by Technical Service Consultants Limited

  This Medical device Alert has been issued due to incompatibility between the neck and cap of the bottle which can cause leakage.

• 28 Jul 2008| Press release: Suspended pharmacist is fined £3,000 for illegal sale and supply of Viagra

  Following a prosecution by the MHRA, Hitendra Patel, a suspended pharmacist, of Worcester Park, Surrey, was fined £3,000 and given a confiscation order of over £200,000 at Kingston Crown Court on 25 July 2008 for illegally selling and supplying the erectile dysfunction medicine Viagra.

• 25 Jul 2008| Request for comments - Guidance on the medical devices vigilance system for CE marked artificial heart valves

  As part of the MHRA's responsibility to ensure medical devices are as safe as possible, we produce vigilance guidance for manufacturers.  We are looking for comments on this document regarding vigilance guidance on CE marked artificial heart valves.

• 25 Jul 2008| Request for comments - Guidance on the In Vitro Diagnostic Medical Devices Vigilance System for Devices for the Measurement of Blood Glucose In the Point of Care Testing and Home Environments

  As part of the MHRA's responsibility to ensure medical devices are as safe as possible, we produce vigilance guidance for manufacturers. We are looking for comments on this document regarding vigilance guidance on devices for the measurement of blood glucose in the POCT and home environments.